Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
NCT ID:
NCT04556734
Description:
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
Frequency Threshold:
5
Time Frame:
From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Study:
NCT04556734
Study Brief:
Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period] | Participants who received placebo matched to etrasimod in DB treatment period, received etrasimod 2 mg orally once daily in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug. | 0 | None | 0 | 4 | 2 | 4 | View |
| DB Treatment Period: Etrasimod 2 mg | Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug. | 0 | None | 0 | 31 | 11 | 31 | View |
| DB Treatment Period: Etrasimod 3 mg | Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug. | 0 | None | 0 | 25 | 12 | 25 | View |
| DB Treatment Period: Placebo | Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug. | 0 | None | 0 | 23 | 11 | 23 | View |
| OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period] | Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 2 mg orally once daily in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug. | 0 | None | 1 | 4 | 3 | 4 | View |
| OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period] | Participants who received etrasimod 3 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug. | 0 | None | 1 | 24 | 14 | 24 | View |
| OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period] | Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug. | 0 | None | 0 | 20 | 11 | 20 | View |
| OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period] | Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug. | 0 | None | 0 | 13 | 11 | 13 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Joint injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.1 | View |
| Gamma-glutamyl transferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 24.1 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 24.1 | View |
| Atrioventricular block second degree | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 24.1 | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 24.1 | View |
| Supraventricular extrasystoles | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 24.1 | View |
| Eye pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 24.1 | View |
| Fuchs' syndrome | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 24.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Gastrointestinal disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.1 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.1 | View |
| Nodule | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.1 | View |
| Limb injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.1 | View |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.1 | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.1 | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.1 | View |
| Electrocardiogram abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.1 | View |
| Tri-iodothyronine free increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.1 | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | View |
| Rotator cuff syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Retinal migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.1 | View |
| Menstruation irregular | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 24.1 | View |
| Postmenopausal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 24.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | View |
| Hypopnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | View |
| Dermatitis atopic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.1 | View |